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CTRI Number  CTRI/2024/12/078079 [Registered on: 13/12/2024] Trial Registered Prospectively
Last Modified On: 20/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of ACUCLOT Biopolymer Hemostatic Sponge in Controlling Bleeding in Trauma-Induced Acute Hemorrhage 
Scientific Title of Study   Haemorrhagic Control Effectiveness of ACUCLOT- Biopolymer based Haemostatic Sponge in Acute Haemorrhage due to Trauma. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
AB/CT/2024/01, Version 1.0 Dated 19-Sep-2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Katam Ram Kumar Reddy 
Designation  Professor of Orthopedics 
Affiliation  Mahatma Gandhi Memorial Hospital 
Address  OPD room no. 08, Department of Orthopedics, Mahatma Gandhi Memorial Hospital, Sherpura, Warangal

Warangal
TELANGANA
506002
India 
Phone  9849255864  
Fax    
Email  krkreddy2009@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Devesh Kumar 
Designation  Director- Clinical Trial Operations  
Affiliation  IR Innovate Research Pvt. Ltd 
Address  IR Innovate Research Pvt. Ltd Gautam Buddha Nagar UTTAR PRADESH

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9971169602  
Fax    
Email  devesh.kumar@innovate-research.com  
 
Details of Contact Person
Public Query  
Name  Dr Devesh Kumar 
Designation  Director- Clinical Trial Operations  
Affiliation  IR Innovate Research Pvt. Ltd 
Address  IR Innovate Research Pvt. Ltd Gautam Buddha Nagar UTTAR PRADESH

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9971169602  
Fax    
Email  devesh.kumar@innovate-research.com  
 
Source of Monetary or Material Support  
Anziam Bio Private Limited E-127 (B), Bhiwadi Industrial Area, Near RIICO Chowk, Bhiwadi-301019 (Rajasthan)  
 
Primary Sponsor  
Name  Anziam Bio Private Limited 
Address  E-127 (B), Bhiwadi Industrial Area, Near RIICO Chowk, Phase – 1, Bhiwadi-301019, Rajasthan 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Katam Ram Kumar Reddy  Mahatma Gandhi Memorial Hospital  OPD Room No. 08, Department of Orthopedics, Mahatma Gandhi Memorial Hospital, Sherpura, Warangal, Telangana- 506002
Warangal
TELANGANA 		 9849255864

krkreddy2009@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kakatiya Institutional Ethics Committee (KIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T149||Unspecified injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AcuClot + Standard of Care  AcuClot will be applied to the bleeding site, providing gentle compression until complete haemostasis is achieved. Duration of participation: 02 days Treatment duration: 02 days  
Comparator Agent  Cotton Gauze + Standard of Care  Cotton Gauze will be applied to the bleeding site, providing gentle compression until complete haemostasis is achieved. Duration of participation: 02 days Treatment duration: 02 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Each patient must meet all of the following criteria to be enrolled in the study:
1. Both Male and Female aged more than and equals to 18 years to less than 65 years.
2. Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to enrollment.
3. Be with Accessible Traumatic Bleedings/Haemorrhage
4. Wound must be bleeding actively at the time of baseline assessment
5. Wound size should be covered by a single available size of study device
6. Subjects willing to comply with the protocol requirements.
 
 
ExclusionCriteria 
Details  Subjects with any of the following conditions will be excluded from the study:
1. Patients who had a prior diagnosis of disease or medical condition affecting the
ability of blood to clot (e.g., hemophilia);
2. A non-survivable injury as per the investigator’s discretion;
3. Patients who, in the opinion of the investigator, may not complete the study for any
reason (e.g., patients requiring immediate suturing);
4. Grossly infected wounds which may require multiple debridement procedures prior
to clearance of bacteria;
5. Patients currently participating in an investigational drug or device study that had
not yet completed its primary endpoint or interfered with procedure and
assessments in this study;
6. Patients with a surgical/iatrogenic wound;
7. Patients with a major head injury, spinal injury, neck injury, abdominal injury, deep
wound injury, fracture, hemorrhagic shock, or foreign materials inside the wound,
such as a stab injury. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluate the efficacy of “AcuClot- Biopolymer based Haemostatic Sponge” (Anziam
Bio Private Limited, Rajasthan India), as a haemorrhage control device in the OutHospital and In-Hospital Settings. 		 Visit 1 (Day 1 ) and Visit 2 (Day 2) 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate the safety of “AcuClot- Biopolymer based Haemostatic Sponge” (Anziam Bio
Private Limited, Rajasthan India), as a haemorrhage control device in the Out-Hospital and In-Hospital Settings. 		 Visit 1 (Day 1 ) and Visit 2 (Day 2) 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/12/2024 
Date of Study Completion (India) 19/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 This study aims to assess the effectiveness and safety of  ACUCLOT Biopolymer Hemostatic Sponge in controlling acute hemorrhage due to trauma. ACUCLOT is a biopolymer-based, non-absorbable hemostatic sponge designed to stop moderate to severe bleeding rapidly. This trial will evaluate the product’s efficacy in both out-hospital and in-hospital settings, focusing on metrics such as time to achieve hemostasis, blood loss, rebleeding incidents, and other side effects. The study will enroll 50 adult participants with trauma-induced hemorrhage and compare ACUCLOT’s performance against conventional cotton gauze, with assessments made at baseline and follow-up after 48 hours.
Overall Conclusion 

             The results of this clinical study clearly demonstrate that the AcuClot Biopolymer-Based Hemostatic Sponge is a significantly more effective, faster-acting, and better-tolerated alternative to conventional Cotton Gauze for the management of acute traumatic bleeding. Among the 50 enrolled participants (25 per group), AcuClot consistently outperformed Cotton Gauze across critical efficacy endpoints. A significantly higher proportion of patients in the AcuClot group achieved hemostasis within 3 minutes (68.00%) compared with Cotton Gauze (37.21%, p = 0.0081), with 20.00% of AcuClot-treated patients achieving hemostasis in under 1 minute compared with only 2.33% in the Cotton Gauze group. The mean total blood loss was also substantially reduced with AcuClot (18.72 ± 6.18 mL) compared with Cotton Gauze (22.28 ± 5.59 mL, p = 0.0379). Furthermore, rebleeding events were rare in the AcuClot group, reported in only 1 patient (4.00%) versus 7 patients (28.00%) in the Cotton Gauze group (p = 0.0206). In addition to superior clinical outcomes, patient-reported measures strongly favored AcuClot. The mean satisfaction score was markedly higher in the AcuClot group (9.64 ± 0.49) compared with Cotton Gauze (6.24 ± 0.66, p < 0.0001). Moreover, 96.00% of AcuClot-treated participants stated they were “very likely” to recommend the product, while no participants in the Cotton Gauze group provided the same response. Importantly, none of the AcuClot group required pressure-based additional interventions, compared with 20.00% in the Cotton Gauze group (p = 0.0160), further underscoring its reliability as a stand-alone hemostatic solution. AcuClot also demonstrated a favorable safety and tolerability profile. No adverse device-related events, allergic reactions, or complications were observed in either group. Wound healing and recovery were comparable between groups, with all participants achieving complete healing without complications, and most resuming normal physical activity within 24–48 hours. These findings confirm that AcuClot’s advanced hemostatic capabilities do not negatively impact the
natural healing process. Collectively, the integration of these clinical and patient-reported outcomes establishes AcuClot as a first-line hemostatic agent in trauma care. Its ability to achieve faster hemostasis, reduce blood loss, minimize rebleeding, and provide superior patient satisfaction, all while maintaining excellent safety, positions it as a valuable advancement in hemorrhage management with the potential to improve patient outcomes and elevate standards of emergency and surgical care.

 
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